510(k) K770722
- Device
- THROMBO SCREEN QUANTITATIVE HEPARIN ASSA
- Applicant
- Bay Area Hema. Onco. Clinic. & Res. L
- 510(k) number
- K770722
- Product code
- JBR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-11
- Date received
- 1977-04-19
- Regulation
- 864.7525
- Classification name
- Test, Heparin Neutralization
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA